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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

IBUPROFEN\PSEUDOEPHEDRINE: 785 Adverse Event Reports & Safety Profile

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785
Total FAERS Reports
5 (0.6%)
Deaths Reported
103
Hospitalizations
785
As Primary/Secondary Suspect
30
Life-Threatening
9
Disabilities

Active Ingredient: IBUPROFEN\PSEUDOEPHEDRINE HYDROCHLORIDE ·

First Report: 2002 · Latest Report: 20250513

What Are the Most Common IBUPROFEN\PSEUDOEPHEDRINE Side Effects?

#1 Most Reported
Drug ineffective
189 reports (24.1%)
#2 Most Reported
Product use in unapproved indication
39 reports (5.0%)
#3 Most Reported
Nausea
38 reports (4.8%)

All IBUPROFEN\PSEUDOEPHEDRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 189 24.1% 1 4
Product use in unapproved indication 39 5.0% 1 1
Nausea 38 4.8% 0 11
Headache 36 4.6% 1 12
Arthralgia 30 3.8% 0 2
Vomiting 30 3.8% 0 20
Drug hypersensitivity 29 3.7% 1 16
Dizziness 27 3.4% 0 8
Drug effective for unapproved indication 27 3.4% 0 0
Dyspnoea 27 3.4% 0 15
Off label use 27 3.4% 1 11
Condition aggravated 26 3.3% 1 4
Pain in extremity 26 3.3% 0 1
Hypersensitivity 25 3.2% 0 1
Drug effect incomplete 22 2.8% 0 0
Swelling 22 2.8% 1 7
Feeling abnormal 20 2.6% 0 0
Musculoskeletal stiffness 20 2.6% 1 2
Overdose 20 2.6% 1 7
Product use issue 20 2.6% 0 2

Who Reports IBUPROFEN\PSEUDOEPHEDRINE Side Effects? Age & Gender Data

Gender: 69.1% female, 30.9% male. Average age: 46.4 years. Most reports from: US. View detailed demographics →

Is IBUPROFEN\PSEUDOEPHEDRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 2 0 2
2005 1 0 0
2006 2 1 1
2007 6 0 0
2008 1 0 0
2009 1 0 1
2010 2 0 1
2012 6 0 2
2013 1 0 0
2014 24 0 2
2015 48 1 10
2016 34 0 9
2017 35 0 10
2018 22 0 5
2019 20 0 4
2020 22 0 8
2021 6 0 3
2022 2 0 0
2023 9 0 2
2024 7 0 2
2025 4 0 3

View full timeline →

What Is IBUPROFEN\PSEUDOEPHEDRINE Used For?

IndicationReports
Product used for unknown indication 133
Nasopharyngitis 125
Nasal congestion 54
Pain 51
Headache 46
Pyrexia 42
Sinus disorder 35
Cough 34
Rhinorrhoea 28
Sinusitis 27

IBUPROFEN\PSEUDOEPHEDRINE vs Alternatives: Which Is Safer?

IBUPROFEN\PSEUDOEPHEDRINE vs ICATIBANT IBUPROFEN\PSEUDOEPHEDRINE vs ICHTHAMMOL\ZINC IBUPROFEN\PSEUDOEPHEDRINE vs ICLUSIG IBUPROFEN\PSEUDOEPHEDRINE vs ICODEXTRIN IBUPROFEN\PSEUDOEPHEDRINE vs ICOSAPENT IBUPROFEN\PSEUDOEPHEDRINE vs ICOSAPENT ETHYL IBUPROFEN\PSEUDOEPHEDRINE vs IDARUBICIN IBUPROFEN\PSEUDOEPHEDRINE vs IDARUCIZUMAB IBUPROFEN\PSEUDOEPHEDRINE vs IDECABTAGENE VICLEUCEL IBUPROFEN\PSEUDOEPHEDRINE vs IDELALISIB

Official FDA Label for IBUPROFEN\PSEUDOEPHEDRINE

Official prescribing information from the FDA-approved drug label.